Principal Medical Writer

GSK•Mississauga, ON

6d•CA$118,000 - CA$168,000•Hybrid

About The Position

The Principal Medical Writer is a seasoned expert who owns complex safety writing deliverables end-to-end. In this role, they independently lead the authoring of high-impact safety documents—such as aggregate reports and Risk Management Plans (RMPs)—translating complex safety data and analyses into clear, compelling outputs. They are accountable for driving timelines, managing stakeholders, and ensuring the quality of safety deliverables that address important safety issues. Beyond day-to-day delivery, this role is a key champion for continuous improvement, best practices, and the smart adoption of new tools and technologies in the safety writing space.

Requirements

Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related field.
Minimum 5 years of advanced medical/regulatory safety writing experience in pharmaceutical, biotech or clinical research settings, including summarization and interpretation of complex data and independent preparation of complex clinical and safety documents for regulatory use.
Advanced understanding of, and ability to apply, statistical, regulatory and medical communication concepts needed to independently write complex safety documents.
In-depth working knowledge of relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements, as well as Good Clinical Practice (GCP).
Strong understanding of core cross-functional clinical research roles and procedures (e.g., safety, regulatory, clinical, epidemiology, statistics and programming) and how they relate to document strategy and operational preparation.
Experience across multiple therapeutic areas, with confidence to quickly dive into new areas without extensive lead time.
Proven ability to manage multiple projects and deadlines in a fast-paced, global/matrix environment, working autonomously while effectively influencing stakeholders.
Strong written and verbal English communication skills and excellent attention to detail.

Nice To Haves

Advanced degree (PhD, PharmD, MSc, MPH) or equivalent scientific training.
Advanced safety writing skills with expertise across most key safety document types and experience leading regulatory submission projects or preparing dossier modules.
Comfort interpreting statistical outputs and collaborating with statisticians on tables and data displays.
Highly collaborative and capable of leading cross-functional, multicultural, and hybrid/distributed teams across regions—negotiating solutions, advising on document structure and content, and working effectively with diverse stakeholders (e.g., health authorities, external partners, contractors/CROs, and patients).
Experience working with external partners, contractors or clinical research organizations, including vendor oversight and coordination.
Prior mentoring, training or people development experience, supporting the growth of less experienced writers and team members.
Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule.
Advanced computer skills and general computer literacy, including comfort with collaboration tools and remote-working technologies.
Excellent English language proficiency, both verbal and written.

Responsibilities

Independently lead preparation of complex clinical and post-market safety documents (e.g., DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions), with strong hands-on experience across all key aggregate safety documents.
Operate effectively within a global, complex matrix organization, working autonomously and confidently influencing stakeholders on process discipline, quality standards, and “how” work should be done.
Lead cross-functional teams to develop content strategy, coordinate contributions, manage review schedules and timelines, and ensure high-quality, fit-for-purpose documents that accurately reflect safety, clinical, and statistical data and meet GSK and global/regional/local regulatory requirements.
Provide oversight to co-authors, vendor writers, and teams of writers—serving as a mentor/buddy, ensuring the quality of contributions, and leading initiatives to improve medical writing processes, including effective use of authoring/review tools and other automation/AI-enabled technology platforms.